FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96289–96312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1996
AFFIRM ONE-STEP HOME PREGNANCY TEST
K962888 · LCX
Athena Medical Corp.
Chemistry · 61d
Cleared Sep 23, 1996
SURESKIN STANDARD, BORDER, AND THIN
K963039 · FRO
Euromed A/S
General & Plastic Surgery · 49d
Cleared Sep 23, 1996
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
K963175 · FTM
Glycar, Inc.
General & Plastic Surgery · 40d
Cleared Sep 23, 1996
ACETAMINOPHEN FLEX REAGENT CARTRIDGE
K963244 · LDP
Dade Intl., Inc.
Toxicology · 35d
Cleared Sep 23, 1996
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
K963246 · ERL
Medtronic Xomed
Ear, Nose, Throat · 35d
Cleared Sep 23, 1996
DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)
K963300 · MQX
Lhasa Medical, Inc.
General Hospital · 33d
Cleared Sep 23, 1996
HICHEM ALP/AMP REAGENT KIT
K963383 · CKF
Hichem Diagnostics
Chemistry · 27d
Cleared Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · LFZ
Abbott Laboratories
Microbiology · 396d
Cleared Sep 20, 1996
CHIPS STANDUP WHEELCHAIR
K955547 · ITI
International Healthcare Solutions, Inc.
Physical Medicine · 290d
Cleared Sep 20, 1996
CHIPS POWERED WHEELCHAIR
K955548 · ITI
International Healthcare Solutions, Inc.
Physical Medicine · 290d
Cleared Sep 20, 1996
ECLIPSE VERSION 3.0
K955577 · OLT
Stellate Systems
Neurology · 317d
Cleared Sep 20, 1996
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE...
K960024 · HQC
Storz Instrument Co.
Ophthalmic · 262d
Cleared Sep 20, 1996
ASTHMA MONITOR
K960078 · BZG
Erich Jaeger, Inc.
Anesthesiology · 259d
Cleared Sep 20, 1996
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · JDB
Wrightmedicaltechnologyinc
Orthopedic · 253d
Cleared Sep 20, 1996
STEP OPTION TO PRISM 2000
K960865 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 200d
Cleared Sep 20, 1996
FLUOROPLUS CARDIAC TV
K961140 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 183d
Cleared Sep 20, 1996
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
K961580 · LJT
Sims Deltec, Inc.
General Hospital · 149d
Cleared Sep 20, 1996
SCARF THREAD-HEAD SCREW
K962236 · HWC
Landos, Inc.
Orthopedic · 101d
Cleared Sep 20, 1996
COBE CENTRYSYSTEM 700 HG HEMODIALYZER
K962427 · KDI
Gambro Healthcare
Gastroenterology & Urology · 88d
Cleared Sep 20, 1996
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
K962465 · DZE
Implant Innovations, Inc.
Dental · 87d
Cleared Sep 20, 1996
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
K962494 · LYC
Usbiomaterials Corp.
Dental · 86d
Cleared Sep 20, 1996
GUGLIELMI DETACHABLE COIL
K962503 · HCG
Target Therapeutics
Neurology · 85d
Cleared Sep 20, 1996
MICRO DIAMOND-POINT DISSECTION NEEDLES
K962544 · JOS
Dsp Worldwide
General & Plastic Surgery · 84d
Cleared Sep 20, 1996
AURORA DIAGNOSTIC WORKSTATION
K962589 · LLZ
Aurora Technology, Inc.
Radiology · 80d